Summary
Vermillion's ovarian cancer test joins a handful of In Vitro Diagnostic Multi-Variant Index Assays (IVDMIAs) approved by the FDA. It is the first and only approved IVDMIA ovarian cancer test. Quest Diagnostics, who worked with Vermillion in developing the test, has a three year exclusive to sell it to reference labs.
Analysis
The American Cancer Society estimates that 21,600 new cases of ovarian cancer will be diagnosed in 2009 and 14,600 women will die from the disease. Ovarian cancer is referred to as the "silent killer" because it is difficult to detect at early, curable stages. CA-125, a biomarker for ovarian cancer has long been used to diagnose this disease along with ultrasound. However, studies have shown that they do not reliably detect ovarian cancer at curable stages.
FDA approval of Vermillion's In Vitro Diagnostic Multi-Variant Index Assay (IVDMIA) is important for several reasons. First, it is the only FDA approved test for the difficult diagnosis of ovarian cancer. Second, it joins a small, but growing list of FDA approved IVDMIAs. This demonstrates that with the appropriate commercialization strategy, FDA approval can be obtained for novel IVDMIAs. FDA approved tests have several advantages over other go-to-market strategies.
Vermillion developed the test in collaboration with Quest Diagnostics. Quest has a three year exclusive license to sell the test to reference labs, while Vermillion can market the test to other clinical diagnostic segments. The test is targeted for a 4Q launch.
For more information on IVDMIAs, Laboratory Developed Tests (LDTs), regulatory issues and the $50 billion dollar global clinical diagnostic market and segments, please contact your GLG representative today to schedule an individual consult.
Ken Powell consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
